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Completed

NCT Number: NCT03214120

Does Modified Ultrafiltration Affect Thromboelastography Results?

The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

About this study

The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will be enrolled. Parents will be consented before surgery.

After weaning from cardiopulmonary bypass and before starting modified ultrafiltration, a TEG sample will be taken. The components studied are Reaction time (R), Coagulation time (K), Angle, Maximum Amplitude (MA) and whole blood clot lysis index at 30 minutes (LY30). Another TEG sample will be taken after finishing modified ultrafiltration and before protamine is given. The different components will be compared pre and after modified ultrafiltration. The Primary end points are the changes of the different TEG components after modified ultrafiltration. The secondary end points are the utilization of different blood products (packed red cells, fresh frozen plasma and platelets transfusion) during and after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- neonates

  • congenital heart disease
  • pediatric cardiac operation with cardiopulmonary bypass
  • modified ultrafiltration done at the end of cardiopulmonary bypass

Exclusion criteria

-patients older than 1 month.

  • Cardiopulmonary bypass is not used
  • Modified ultrafiltration is not performed

Treatment and study plan

Primary outcomes

  1. change in thromboelastography components after modified ultrafiltration

    Time frame: 1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit)

    effect of modified ultrafiltration on different components of thromboelastography

Secondary outcomes

  1. blood products utilization during and after surgery

    Time frame: initial phase of recovery (2 days) in the intensive care unit after cardiac surgery

    use of packed red cells, fresh frozen plasma and platelets during or after surgery

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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